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Based on record review and interviews with hospital staff, governing body does not show oversight of hospital operations to assure the quality of care provided to patients. As surveyed the hospital does not meet Medicare Conditions for Participation for Governing Body; Nursing; Pharmaceutical Services; Dietary and Infection Control.

Findings:

1. The hospital did not have evidence that a registered nurse is directing and responsible for nursing service and is actively involved in overseeing nursing policy and procedure, training and competency of nursing personnel, and nursing quality initiatives.

a. The hospital failed to ensure nursing services were under the direction and responsibility of one registered nurse. Refer to tag A-0385

b.. The hospital failed to ensure adequate numbers of trained nursing personnel were available to meet the needs of the patient population. Refer to tag A-0392

c. The hospital failed to ensure non employee clinical personnel are adequately oriented, trained, and competent. Refer to tag A-0398.



2. The hospital did not have evidence that a registered pharmacist is directing the hospital's pharmaceutical services and is actively involved in directing these services to provide safe and effective drugs and medications.

a. The hospital does not have evidence of a registered pharmacist who has been directing pharmaceutical services. See Tag 492, Pharmacist Responsibilities.

b. The hospital does not have a drug accountability system to ensure that current and accurate records are kept of the receipt and distribution of all scheduled drugs in a readily retrievable manner. See Tag 494, Pharmacy Drug Records.

c. The hospital does not ensure that current and accurate records are kept of the receipt and distribution of all scheduled drugs. See Tag 500, Delivery of Drugs.

d. The hospital does not have a system to report medication errors and adverse drug reactions and to analyze these to identify and implement potential corrective actions through the hospital-wide quality assurance program. See Tag 508, Reporting Adverse Events.

3. The hospital does not ensure there is a organized dietary service with oversight by a registered dietitian. The hospital did not have evidence that a dietitian was providing oversight or services with regularly scheduled visits.

a No dietitian reports were provided during the survey to show the dietitan was actively supervising dietary services at the hospital. A contract was provided showing that the hospital had a contract with a dietitian to provide services as the manager for the dietary department of the hospital for a minimum of 25 hours a week. The contract was signed in 2005. Surveyors were told by Staff C the dietitian had not provided reports since 2005. Refer to tag 0621

b. Meeting minutes reviewed for 2009 and 2010 did not document that a dietitan was attending or providing reports in any of the hospital's meetings such as medical staff, committee of the whole or governing board. Refer to tag 0621

c. Dietary policies and procedures were provided to surveyors 7/27/2010. None of the policies had been approved by the dietitian, medical staff, or governing body. Most of the policies had not been revised since 2005. The Oklahoma Therapuetic Dietary Manual did not have approval signatures from the dietitian or the medical staff. Governing Body Meeting and Medical Staff meeting minutes did not indicate a review and approval of the manual had occurred. Refer to Tag 0631.

d. Personnel records of staff indicated as providing dietary services did not have dietary training, competency, or evaluation. Refer to tag 0622.

4. The hospital failed to maintain an active ongoing program to prevent, control, investigate and provide corrective actions to minimize infections and communicable diseases in patients and staff.

a. The hospital does not have a designated infection control officer trained in the principals and methods of infection control. Please refer to Tag A0748.

b. The hospital's approved disinfectant, used hospital-wide, is not EPA (Environmental Protection Agency)-registered and the label documents it is for home/office use, not hospital use. Please refer to Tag A0749

c. The hospital's infection control program did not review its sterilization practice with corrective actions to limit the use of unwrapped/"flashed" instruments. Please refer to Tag A0749.

d. The hospital failed to ensure infection control activities and issues were monitored, reviewed and analyzed with corrective actions to prevent, identify and manage infections and communicable diseases with measures that result in improvement on an ongoing basis. Please refer to Tag A0756.

5. The hospital failed to provide follow-up action for an identifed problem. Committee of the Whole Meeting Minutes for May 19, 2010 documented the blood bank refrigerator alarm had not been connected. A surveyor and staff A went to the blood bank refrigerator area. Staff A was not aware the refrigerator was not functioning appropriately. There were temperature graphs for the refrigerator but Staff A did not know if they were in range or not. When reviewed in the exit conference with Staff A , Staff B, Staff C, and Staff D, Staff C stated that was supposed to have been fixed. No further evidence was provided the alarm on the blood bank refrigerator had been repaired. During the exit conference on 07/30/2010, Staff B stated the identified problem had not been fixed.

Based in record review and interviews with facility staff, the ASC does not ensure that all practitioners are working within their scope of privileges while providing patient care. One ( I - 1) of seven ( A-1, B-1,C-1, D-1, E-1, F-1, H-1 ) surgeons performing orthopedic and neuro surgeries did not have current privileges granted for the surgery performed. The surgeon performed an "extreme lateral interbody fusion of the lumbar 4 and 5; reinstrumentation of lumbar 4 and 5; ROH (removal of hardward) before TLIF ( transforaminal lumbar interbody fusion ) reinstrumentation.)

Based on review of staffing records, job descriptions, time sheets, surgery logs, observation and interviews with hospital staff, the hospital does not ensure the organized nursing service provides safe delivery of patient care. The hospital does not comply with Medicare Condition of Participation: 482.23 Nursing Services.

Findings:

1. The hospital failed to ensure nursing services were well organized and under the direction and responsibility of one registered nurse. Refer to tag A-0386

2. The hospital failed to ensure adequate numbers of trained nursing personnel were available to meet the needs of the patient population. Refer to tag A-0392

3. The hospital failed to ensure non-employee clinical personnel are adequately oriented, trained, and competent. Refer to tag A-0398.

Based on administrative staff interviews and review of hospital documents and nursing personnel files, the hospital failed to ensure there is a director of the nursing services (DON), that is a licensed registered nurse responsible for the operation of nursing services and the delivery of nursing care for all areas of the hospital.

Findings:

1. At the entrance conference on 07/27/2010, the surveyors asked for the name of the DON. Staff C and D stated Staff A and B were "sharing the position". Later in the morning Staff C was asked again about the Director of Nursing (DON). Staff C stated Staff A was the DON. After staff C left the room, Staff A stated she was not the Director of Nurses. In a interview on 7/28/2010, Staff B was asked if she was the Director of Nurses. Staff B stated she was the director of surgical services. On 7/29/2010, Staff C told surveyors she had been misinformed and staff A was not the Director of Nurses.

2. Personnel records for staff A and B were provided to surveyors on 7/27/2010.
A. Staff A's personnel record reflected her title was changed from staff nurse to "clinical manager" on 5/20/2010. There was no job description for clinical manager or director of nurses in Staff A's personnel file.

B. Staff B's personnel record reflected her title was changed on 6/1/09 from Director of Nursing to Director of Surgical Services. There were no other documents indicating Staff B was the current Director of Nursing.

3. Surveyors requested the organizational chart on 7/27/2010. The Director of Nursing was left blank on the chart provided for review.

Based on a review of policies and procedures, staffing sheets, surgery and postanesthesia logs, and staff interviews, the hospital failed to ensure there were sufficient numbers of registered nurses to provide each unit with the immediate availability of an RN for bedside care.

Findings:

1. Administrative staff (Staff A and B) told the surveyors that nursing staff worked 12-hour shifts (7 a.m. to 7 p.m. and 7 p.m. to 7 a.m.) on the inpatient nursing floor. Staff B stated the operating room nurses and post anesthesia staff worked around the operating room schedule and their hours varied. Staff A and Staff B confirmed with surveyors they and the nursing staff were utilized in both the hospital and the adjoining separately licensed and certified ambulatory surgery center. Staff B told surveyors the ambulatory surgery center's staff was provided to the hospital by contract/service agreement.

2. Surveyors requested nurse staffing, operating and postanesthesia room logs for June and July 2010. Surveyors also reviewed time sheets for June and July 2010 of the employees listed in both logs. Upon review of timesheets and logs surveyors were unable to correlate hours worked by staff documented as being being present in the operating room and post anesthesia logs.

3. On 7/30/2010 in separate interviews with a surveyor, Staff G and Staff U stated they would perform duties during their scheduled shifts in both facilities, sometimes on the same day. They stated they did not know where they would be assigned until they came in to the facility (either the hospital or the adjacent ambulatory surgery center) and their assignments were on a case by case basis as to which facility they would work in.

4. On 7/27/2010 fourteen personnel files were requested and provided to surveyors. Surveyors asked for orientation and training documents provided to hospital staff specific to the areas each person was working in. On July 28, 2010 at 1310 surveyors were provided a document "perioperative staff orientation checklist" which Staff B informed surveyors was the correct orientation and training form. Ten of ten personnel listed as working in the hospital operating room or post anesthesia care did not have this document in their file. Ten of ten did not have documentation they were oriented and trained in the hospital.

Based on review of personnel files and interviews with hospital staff, the hospital failed to ensure the Director of Nursing, or designee, provided orientation and evaluation of agency nursing personnel. This occurred for one of one agency personnel requested for review.

Findings:

1. The surveyors requested 15 personnel records (A,B,C, D, E, F, G,H,I,J,K,L,M, N, Q). One personnel record Staff Q was agency personnel. The records provided to surveyors the afternoon of 7/29/2010 contained information from the agency. There was no documentation provided in the agency personnel record the hospital had oriented, trained, or evaluated care provided by the agency staff.

2. This finding was reviewed with administration on the afternoon of 7/30/2010. No further information was provided.

Based on a review of closed medical records, staff interviews, and clinical personnel files, the hospital failed to ensure blood transfusions were administered per hospital regulations. There was no evidence of staff training in administration of blood or blood products.

Findings;

1. On 7/27/2010, surveyors requested blood administration education and training for clinical staff. No education and training was provided. Staff A was asked what type of training nurses received on administration of blood. Staff A stated there was no special training for blood administration. This was also verified with Staff B.

2.. On 7/27/2010, surveyors requested blood administration policies and procedures. Four policies were received for review: "Forms Used when Blood Products are Used, Dispensing of Blood Product from Lab, Specific Situations in Blood Product Administration, Routine Blood Administration". None of the policies had effective dates, approval or revision dates. There were no meeting minutes in medical staff, committee of the whole, or governing body where the policies had been approved.

3. Committee of the Whole Meeting Minutes for May 19, 2010 documented the blood bank refrigerator alarm had not been connected. A surveyor and staff A went to the blood bank refrigerator area. Staff A was not aware the refrigerator was not functioning appropriately. There were temperature graphs for the refrigerator but Staff A did not know if they were in range or not. When reviewed in the exit conference with Staff A , Staff B, Staff C, and Staff D, Staff C stated that was supposed to have been fixed. No further evidence was provided the alarm on the blood bank refrigerator had been repaired.

4. Pt # 1 and the patient mentioned in the complaint received multiple units of packed red blood cells, fresh frozen plasma, and platelets. The dictated operative note indicated multiple blood products were received in the operating room. There was no documentation in the circulating nursing notes or anesthesia notes indicating the types of products received, identification of the products, or total volume of products received.

5. Pt #11 received multiple units of packed red blood cells and fresh frozen plasma. The dictated operative note indicated one unit of blood was transfused in the operating room. There was no documentation in the circulator notes or anesthesia notes indicating any blood product was infused during the operative period. This finding was reviewed with Staff B. No further documentation was provided.

Based on record review and interviews with hospital staff, the hospital does not ensure that the pharmaceutical needs of the patients are met. The hospital did not have evidence that a registered pharmacist is directing the hospital's pharmaceutical services and is actively involved in directing these services to provide safe and effective drugs and medications. The hospital does not comply with Medicare Condition of Participation: 482.25 - Pharmaceutical Services.



Findings:

1. The hospital does not have evidence of a registered pharmacist who has been directing pharmaceutical services. See Tag 492, Pharmacist Responsibilities.

2. The hospital does not have a drug accountability system to ensure that current and accurate records are kept of the receipt and distribution of all scheduled drugs in a readily retrievable manner. See Tag 494, Pharmacy Drug Records.

3. The hospital does not ensure that current and accurate records are kept of the receipt and distribution of all scheduled drugs. See Tag 500, Delivery of Drugs.

4. The hospital does not have a system to report medication errors and adverse drug reactions and to analyze these to identify and implement potential corrective actions through the hospital-wide quality assurance program. See Tag 508, Reporting Adverse Events.

Based on record review and interviews with hospital staff the hospital does not ensure that a registered pharmacist is responsible for all the pharmaceutical services of the hospital. The hospital did not have evidence that a pharmacist was providing pharmacy services with regularly scheduled visits.

Findings:

1. No pharmacist reports were provided during the investigation to show the pharmacist was actively supervising pharmaceutical services at the hospital.

2. Meeting minutes reviewed for 2009 and 2010 did not document that a pharmacist was attending or participating in any of the hospital's meetings such as medical staff, committee of the whole or governing board.

3. No contract was provided showing that the hospital had a contract with a pharmacist to provide services to the hospital as required.

4. Hospital Staff C stated on the morning of July 27, 2010 that they had not had a contract with the pharmacist since July 9, 2010.

5. Hospital Staff A stated on the afternoon of July 29, 2010 that she and Staff B had taken over the job of ordering the Scheduled drugs, but the pharmacist had previously done the ordering.

6. No records were available to show the pharmacist is responsible for determining that all drug records are in order and that an account of all scheduled drugs is maintained and reconciled.

Based on record review and interviews with hospital staff, the hospital does not ensure that current and accurate records are kept of the receipt and distribution of all scheduled drugs. The hospital does not have a record system to account for the control of the distribution, use and disposition of all scheduled drugs.

Findings:

1. The hospital does not have a record system in place that tracks the movement of scheduled drugs when they enter the hospital until they are administered to a patient, destroyed or returned to the manufacturer.

2. No narcotic administration records were available for review to show what scheduled drugs were administered to each patient, the person administering, the physician who ordered the drugs, the dose and wastage if any and the date each drug was administered.

3. Hospital Staff B stated on the afternoon of July 29, 2010 that the they do not keep the records from the Pyxis, an automated drug dispensing machine where the scheduled drugs are stored. One machine is located in the hospital medication room and one in the operating suite.

4. Schedule II drugs, which are required to be ordered using a DEA (Drug Enforcement Agency) Form 222 were ordered by the adjacent separately licensed and certified Ambulatory Surgical Center (ASC) using a DEA Form 222, however, the scheduled drugs ordered by the ASC were utilized by both the hospital and the ASC. The hospital and the ASC are separate free standing facilities that are co-located within the same building. The hospital is on the second floor and the ASC is on the first floor. Each entity has a separate address, separate state license number, and separate CMS Certification Number (CCN). Hospital/ASC records show all drugs are ordered and used by both the hospital and the separately licensed and certified ASC as if they were a single entity. This arrangement was verified by interview with ASC staff D on the afternoon of July 30, 2010. The scheduled drugs used by both the hospital and the separately licensed and certified ASC are ordered by the ASC on DEA Form 222 and are then stored in a cabinet within the hospital. These scheduled drugs are then further distributed from this cabinet among and two Pyxis machines located in the hospital and one Pyxis machine located in the adjacent separately licensed and certifiedASC.

5. Hospital Staff A stated on the afternoon of July 29, 2010 that the hospital does not have an account with the wholesaler so all the scheduled drugs were ordered on the ASC's DEA Form 222s. The scheduled drugs are not transferred to the hospital via a separate DEA Form 222 as required by Federal regulation.

Based on record review and interviews with staff, the hospital does not ensure that current and accurate records are kept of the receipt and distribution of all scheduled drugs and scheduled drugs are controlled and distributed in accordance with Federal and State regulations.

Findings:

1. No records were available to show the pharmacist is responsible for determining that all drug records are in order and that an account of all scheduled drugs is maintained and reconciled. The hospital did not have Narcotic administration records to show the movement of scheduled drugs from point of entry until administered, wasted or returned to the manufacturer.

2. Hospital Staff B stated on the afternmoon of July 29, 2010 that the they do not keep the records from the Pyxis (an automated drug dispensing machine where the scheduled drugs are stored) past 30 days.

3. Schedule II drugs which are required to be ordered on a DEA Form 222 were ordered on the forms from the adjacent separately licensed and certified ASC, not the hospital. The hospital and the ASC are separate free standing facilities that are in the same building, but have separate addresses.

4. The schedule II drugs that were ordered for the hospital on the separately licensed and certified ASC's DEA Form 222s were not kept in the ASC, but were stored and used both in the hospital and the ASC without transferring the drugs as required using the proper DEA forms.

4. The hospital does not have evidence to show the pharmacist was actively supervising pharmaceutical services at the hospital, reconciling schedule drug administration, and overseeing that medications are administered as ordered.

Based on record review and interviews with hospital staff, the hospital does not have a system to report medication errors and adverse drug reactions and to analyze these to identify and implement potential corrective actions through the hospital-wide quality assurance program.

Findings:

1. Meeting minutes reviewed for 2009 and 2010 did not document that a pharmacist was attending or participating in any of the hospital's meetings such as medical staff, committee of the whole or governing board.

2. The meeting minutes from the meetings mentioned above did not have evidence of a review of medication errors or adverse drug events.

Based on record review and interviews with hospital staff the hospital does not ensure there is a organized dietary service with oversight by a registered dietitian. The hospital did not have evidence that a dietitian was providing oversight or services with regularly scheduled visits.

Findings:

1. No dietitian reports were provided during the survey to show the dietitan was actively supervising dietary services at the hospital.

2. Meeting minutes reviewed for 2009 and 2010 did not document that a dietitan was attending or providing reports in any of the hospital's meetings such as medical staff, committee of the whole or governing board.

3. Dietary policies and procedures were provided to surveyors 7/27/2010. None of the policies had been approved by the dietitian, medical staff, or governing body. Most of the policies had not been revised since 2005.

4. A contract was provided showing that the hospital had a contract with a dietitian to provide services as the manager for the dietary department of the hospital for a minimum of 25 hours a week. The contract was signed in 2005. Surveyors were told by Staff C the dietitian had not provided reports since 2005.

5. Personnel records of staff indicated as providing dietary services did not have dietary training, competency, or evaluation.

Based on review charts, dietary policy and procedure, and interviews with staff, the hospital failed to require that the dietitian supervise the nutritional aspects of a patient's nutritional care.

Findings:

1. On 7/27/2010 Staff A told surveyors, staff nurses complete an inpatient admission assessment when patients enter the hospital, part of the assessment is an area of documentation named "nutritional assessment". Listed are diets, dietary, and dental conditions. The conditions are as follows: healthy heart, "ADA_____", renal diet, low sodium, enteral/parenteral nutrition, difficulty chewing /swallowing, unable to take nourishment for 3 days, unintentional weight change (+ or - 10% of weight, referral to physician, referral to dietitian." After the list of conditions there is a statement "if any of the above checked other than regular, please contact dietitian." Four of ten (#1,2, 3,4) charts had documentation that triggered a automatic review by the dietitian. Four of four charts had not been reviewed.

A. Patient #1 a 67-year-old female, was admitted 5/1/10 for surgery with a history of diabetes. The nutritional assessment on the chart had a check mark by the word diabetic. There was no documentation the diabetic order had been reviewed by the CDM or the dietitian.
B. Patient #3 a 67 year old female, was admitted 3/30/2010 for surgery. Dietary orders in the chart were for a 1800kcal diet. There was no evidence in the chart the order had been reviewed by the CDM or the dietitian. There was no documentation provided the patient received a 1800 kcal diet.
C. Patient #4 a 68 year old male, was admitted 4/22/2010 for surgery. Dietary orders in the chart were for a 2 gram sodium diet. The nursing assessment indicated the patient was on a regular diet. There was no documentation the 2 gram sodium diet had been reviewed by the CDM or the dietitian. There was no documentation provided the patient received a 2 gram sodium diet.
D. Patient #2 a 47 year old male, was admitted 6/25/2010 for surgery. Documentation in the nursing assessment shows a check mark by "difficulty chewing". "No top teeth" was documented on the assessment as well. There was no chewing/swallowing assessment completed. A regular diet was ordered. There was no documentation the dietitian or CDM had reviewed the chart.


2. On 7/27/2010 surveyors requested consultant dietitian reports. In the morning on 7/27/2010 Staff C stated the facility could not find a report from the dietitian since 2005. Later in an interview at 1515, Staff F, certified dietary manager (CDM), stated the consultant dietitian had not provided any consulting report for the facility since May of 2009.

3. On 7/27/2010 Staff F stated that the consultant dietitian is available for telephone consult but there is very rarely a need to call the dietitian. A surveyor asked about diabetic diets, special diets etc. and Staff F stated the facility "doesn't have patients like that". The surveyor also asked for menus and Staff F said there are no menus. Patients are given a "likes/dislikes" sheet to choose from. The surveyor asked who prepared and served meals and were told by Staff F that she and the nursing staff provided this service to patients. Surveyors asked if anyone had received training by the dietitian on food preparation, storage and handling specific to the dietary department at the hospital. Staff F stated there had not been any specialized training or orientation to the dietary department at the hospital. Staff F was not aware of any training or competencies developed by the dietitian for Staff F or the nursing personnel. Staff F told surveyors she also worked as a transporter and surgery scheduler. Staff F could not verify how many hours a week was utilized in dietary. Surveyors reviewed Staff F's personnel file. The file did not contain a job description for CDM or training and competencies as CDM at the hospital.

4. On 7/27/2010 Staff A was asked about training for nursing personnel regarding dietary. Staff A stated she had not received any training and she was not aware of any training for the nursing staff. Staff A told surveyors staff had concerns about sanitation as the nursing staff are also instructed to clean rooms. The surveyor asked if there were any cover gowns or aprons used during the cleaning of rooms or preparation of food. Staff A told surveyors gloves were used to clean the patient rooms but there were no cover gowns or aprons available. Staff A's personnel file was reviewed by surveyors. The file did not contain specific training or competencies in dietary.

5. On 7/28/2010 during a tour of the nursing floor and dietary department, Staff E told surveyors she was one of the staff that cooked and prepared meals for patients. Surveyors asked if there had been any special training by the CDM or the dietitian. Staff E told surveyors there had not been any specific training. Staff E confirmed with the surveyor there were no aprons or gowns used in preparation of food or during the cleaning of rooms. Staff E also stated gloves were not used during food preparation or after meal tray handling. Staff E was asked how the hospital provided for diabetic patients. Staff E stated "we are doing better since Staff A was hired. We look at carbohydrates but we only have frozen dinners and there has not been any conversion on these. We do have low-fat cheese and sugar free jello for the diabetic patients now." Staff E stated there had not been any training on portion control or portion sizes. Staff E confirmed there were no menus provided to patients. Staff E stated "I go in and review with patients their likes and dislikes sheet when I am preparing meals because sometimes we don't have what's on the list. I don't want them to have the expectation they are going to get something we don't have". Staff E stated she had never seen the dietitian in the facility. Staff E's personnel file was reviewed by surveyors. The file did not contain specific training or competencies in dietary.

Based on review of policies, personnel files, and interviews, the hospital failed to provide adequate training and oversight to dietary and nursing personnel.

Findings:
1. On 7/27/2010 surveyors asked Staff A who was responsible for preparation and delivery of dietary trays. Staff A stated sometimes Staff F will "come up from surgery and prepare trays. All of the evening trays are prepared by the evening nursing staff. Three personnel records of employees told to surveyors as working in the dietary area were selected. Three of three records (A, E, F) did not have specific dietary department training or competencies.

2. On 7/27/2010 Staff F provided surveyors with a certification as dietary manager. Staff F told surveyors she and the nursing staff were responsible for providing the appropriate diets to patients. The surveyor also asked for menus and Staff F said there are no menus. Patients are given a "likes/dislikes" sheet to choose from. Surveyors asked if anyone had received training by the dietitian on food preparation, storage and handling specific to the dietary department at the hospital. Staff F stated there had not been any specialized training or orientation to the dietary department at the hospital. Staff F was not aware of any training or competencies developed by the dietitian for Staff F or the nursing personnel. Staff F told surveyors she also worked as a transporter and surgery scheduler. Staff F could not verify how many hours a week was utilized in dietary. Surveyors reviewed Staff F's personnel file. The file did not contain a job description for CDM or training and competencies as CDM at the hospital.

3. On 7/27/2010 Staff A was asked about training for nursing personnel regarding dietary. Staff A stated she had not received any training and she was not aware of any training for the nursing staff. Staff A told surveyors staff had concerns about sanitation as the nursing staff are also instructed to clean rooms. The surveyor asked if there were any cover gowns or aprons used during the cleaning of rooms or preparation of food. Staff A told surveyors gloves were used to clean the patient rooms but there were no cover gowns or aprons available. Staff A's personnel file was reviewed by surveyors. The file did not contain specific training or competencies in dietary.

4. On 7/28/2010 during a tour of the nursing floor and dietary department, Staff E told surveyors she was one of the staff that prepared meals for patients. Surveyors asked if there had been any special training by the CDM or the dietitian. Staff E told surveyors there had not been any specific training. Staff E confirmed with the surveyor there were no aprons or gowns used in preparation of food or during the cleaning of rooms. Staff E also stated gloves were not used during food preparation or after meal tray handling. Staff E was asked how the hospital provided for diabetic patients. Staff E stated "we are doing better since Staff A was hired. We look at carbohydrates but we only have frozen dinners and there has not been any conversion on these. We do have low-fat cheese and sugar free jello for the diabetic patients now." Staff E stated there had not been any training on portion control or portion sizes. Staff E confirmed there were no menus provided to patients. Staff E stated "I go in and review with patients their likes and dislikes sheet when I am preparing meals because sometimes we don't have what's on the list. I don't want them to have the expectation they are going to get something we don't have". Staff E stated she had never seen the dietitian in the facility. Staff E's personnel file was reviewed by surveyors. The file did not contain specific training or competencies in dietary.

Based on a review of closed records and staff interviews, the hospital failed to ensure the meals were meeting the needs of the patients. In four of four (#1, 2, 3, 4) patients requiring special diets or with dietary conditions requiring dietitian intervention there was no documentation by the dietitian to assess the needs of the patients.

Findings:

1. Patient #1 a 67-year-old female, was admitted 5/1/10 for surgery with a history of diabetes. The nursing assessment on the chart had a check mark by the word diabetic. There was no documentation the diabetic order had been reviewed by the CDM or the dietitian. There was no documentation to reflect the patient received a diabetic diet.

2. Patient #3 a 67 year old female, was admitted 3/30/2010 for surgery. Dietary orders in the chart were for a 1800 kcal diet. There was no evidence in the chart the order had been reviewed by the CDM or the dietitian. There was no documentation provided the patient received a 1800 kcal diet.

3. Patient #4 a 68 year old male, was admitted 4/22/2010 for surgery. Dietary orders in the chart were for a 2 gram sodium diet. The nursing assessment indicated the patient was on a regular diet. There was no documentation the 2 gram sodium diet had been reviewed by the CDM or the dietitian. There was no documentation provided the patient received a 2 gram sodium diet.

4. Patient #2 a 47 year old male, was admitted 6/25/2010 for surgery. Documentation in the nursing assessment shows a check mark by "difficulty chewing". "No top teeth" was documented on the assessment as well. There was no chewing/swallowing assessment completed. A regular diet was ordered. There was no documentation the dietitian or CDM had reviewed the chart.

5. During an interview with the Staff F, certified dietary manager (CDM) on 07/27/2010 at 1515, the CDM was asked about special diets for patients. Staff F stated the facility did not have "patients like that".

6. During a tour of the dietary department on 7/28/2010, Staff E stated the facility did not have specific diets for diabetics. This finding was also confirmed on 7/28/2010 with Staff A.

Based on observations and interviews, the hospital failed to ensure that the current/ latest edition of the Oklahoma Diet Manual is available to all medical and nursing personnel.

Findings:

1. The hospital's diet manual was the latest Oklahoma Diet Manual (which is the 12th edition, 2006, Oklahoma Nutrition Manual). The Oklahoma Diet Manual was not approved by the licensed/registered dietitian and medical staff. This finding was reviewed with administration in the exit conference 7/30/2010 and no further evidence was offered.
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Based on interviews with staff and review of hospital documentation the hospital failed to maintain an active ongoing program to prevent, control, and investigate infections and communicable diseases minimize infections and communicable diseases in patients and staff. The hospital does not comply with Medicare Condition of Participation: 482.42 Infection Control.

Findings:

1. The hospital does not have a designated infection control officer trained in the principals and methods of infection control.. Please refer to Tag A0748.

2. The hospital's approved disinfectant, used hospital-wide, is not EPA (Environmental Protection Agency)-registered and the label documents it is for home/office use, not hospital use. Please refer to Tag A0749

3. The hospital's infection control program did not review its sterilization practice with corrective actions to limit the use of unwrapped/"flashed" instruments. Please refer to Tag A0749.

4. The hospital's infection control program did not specify the types and frequencies of surveillance activities. Staff A told the surveyors that she was using the monitoring tools left by the previous person responsible for infection control. Monitoring activities, provided for review, did not include active surveillance of the practices to ensure staff adhered to the policies to avoid possible transmission of infections.

5. The hospital failed to ensure infection control activities and issues were monitored, reviewed and analyzed with corrective actions to prevent, identify and manage infections and communicable diseases with measures that result in improvement on an ongoing basis. Please refer to Tag A0756.

Based on review of the hospital's policies and procedures, meeting minutes, and personnel files, and interviews with staff, the hospital failed to designate the Infection Control professional in writing and the Infection Control program is not under the direction of a qualified professional trained in the principals and methods of infection control.

Findings:

1. Administrative staff told the surveyors that Staff A was the hospital's Infection Control Administrator/Coordinator/Preventionist/Nurse.

2. Review of the hospitals's meeting minutes, Governing Body, Medical Executive Committee and Committee of the Whole, did not show the hospital had designated Staff A as the practitioner to direct the hospital's infection control program.

3. Review of Staff A's personnel file did not contain evidence Staff A had been designated as the infection control practitioner. The file did not contain a job description for infection control nurse/practitioner. The file did not contain documentation that Staff A had been trained on the principals and methods of infection control.

4. Staff A stated on 07/27/2010 and again on 07/29/2010 that she had not received any training in infection control. She stated as far as she knew no written designation of her as the infection control practitioner had been performed and she had not been given a job description for infection control practitioner.

Based on review of the hospital's documents and interviews with staff, the hospital failed to ensure the infection control practitioner developed and implemented an ongoing infection control program based on nationally recognized infection control guidelines and designed to identify, prevent, control and investigate infections and communicable diseases of patients and personnel.

Findings:

1. The hospital's policy, entitled Infection Control for Environmental Services with an effective date of January 22, 2009, stipulated the hospital would use an EPA (Environmental Protection Agency)-registered tuberculocidal hospital - grade disinfectant.

2. Staff responsible for infection control had not reviewed the disinfectant used in the facility to ensure it was appropriate. The hospital's approved disinfectant used throughout the facility, Sani Shield, is not an EPA-registered agent. The label on the container stated it was safe for home use. This finding was reviewed and verified with the Director of Surgical Services on the afternoon of 07/29/2010.

3. Staff A told the surveyors that she was using the monitoring tools left by the previous person responsible for infection control. She stated on the afternoon of 07/29/2010 that her observations had not included cleaning techniques to ensure disinfectants were applied according to manufacture guidelines. She stated that since nursing cleaned the unit, she had only watched cleaning on the inpatient unit one time to ensure all surfaces were wiped.

4. Monitoring activities, provided for review, did not include active surveillance of the practices to ensure staff adhered to the policies to avoid possible transmission of infections.

5. The infection control program did not evaluate all staff and credentialed personnel for immunization status as recommended by the CDC(Centers for Disease Control and Prevention) and its Advisory Committee on Immunization Practices. Seven of eleven physicians' and three of five allied health files reviewed did not contain complete immunization histories. Staff D and Q, agency/contract staff, did not have health files, confirmed with the Corporate Compliance Officer on 07/28/2010.

6. The hospital did not have a policy and procedure with information on the communicable diseases reportable to the Oklahoma State Department of Health and did not explain the procedure to report these diseases.

7. The hospital did not monitor its policy and procedure for sterilization. The hospital's policy, entitled Pre-Vacuum Sterilization with an effective date of January 22, 2009, stipulated, "The Pre-Vacuum Sterilizer is run on a cycle of four (4) minutes sterilization time, and twenty (20) minutes dry time, at 135 degrees C (Celsius) on the Wrapped Cycle." Prior to 07/22/2010, all cycles were ran at 4 minutes sterilization and 15 minutes dry time.

8. The hospital did not monitor its use of "flash" sterilization. The "Flash Sterilization Protocol" given to the surveyors and indicated as the one used stipulated, " 1. Sterilization of unwrapped/uncontained loads may be utilized for an urgent and unpredicted need for a device. I.e. (sic) an instrument that is dropped during the procedure; and there is not another sterile one to replace it. The dropped item will be washed before being put in the sterilizer. 2. Routine sterilization of unwrapped/uncontained loads is inappropriate and will NOT be done. ...4. All items 'flashed' will be entered in the 'Flash Sterilization Log'. a. The log will include the load#, date, item flashed, patient item used on, cycle used, time of cycle and the indication for the flashing and operators initials."

Clarification from the Centers for Medicare and Medicaid Services (CMS) on September 4, 2009, defined, "Flash sterilization has traditionally referred to a very short sterilization cycle for a very small and unwrapped load... Because the load was unwrapped, the sterility of the device could not be maintained after it was removed from the sterilizer. Sterilization of unwrapped/uncontained loads should not be routine practice in ASCs (ambulatory surgery centers), but should be used only for an urgent and unpredicted need for a specific device." This clarification should also apply to hospitals.

The Centers for Disease Control and Prevention (CDC -- from Infection Control and Hospital Epidemiology, "Guideline for Prevention of Surgical Site Infection", April 1999, page 261; and from Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, page 61) and the Association of Operating Room Nurses (AORN -- Perioperative Standards and Recommended Practices, pages 578 through 581, 2008 edition) do not recommend the use of "flash" sterilization for the routine sterilization of instruments, reasons of convenience or as an alternative to purchasing additional instrument sets or to save time. "Flash" sterilization, according to current CDC guidelines, should be limited to the purpose of sterilizing a surgical instrument in an emergency, such as when a needed instrument has been dropped or otherwise become contaminated.

a. Review of the hospital's "Flash Sterilization Log" showed 49 loads of flash cycles were run in June and July 2010. Staff B told the surveyor on 07/29/2010 that the hospital and ambulatory surgery center shared instruments. She stated that between the two, they had 2 sets of Frazier instrument sets, 6 Basic instrument sets, 2 Major Orthopedic sets, 2 Total Performance Systems (TPS) and 2 Lumbar (ACD) sets.

i. The entries for June showed showed 33 flash cycles with only a one minute dry time. Twenty-four of the loads did not contain the name of the patient for whom the instruments were used. None of the loads documented "E" (dropped/contaminated instrument) as the reason for flash. Nine flash cycles of TPS were done with the reason for flash as "B" (sterile instrument set unavailable). Other instruments flashed included ACD, Lumbar, Arthroscopic and Basic.

ii. The entries for July log showed 16 loads of instruments were flashed. Ten of the did not contain the name of the patient for whom the instruments were used. Only three of the loads documented "E" as the reason for flash. Three loads did not document a reason for the flash. Two of the loads documented "C" (instrument brought in unsterile by Company) as the reason for flash. The log documented two loads of Frazier instruments and two loads of TPS were flashed.

b. The Flash Sterilization Report did not contain areas for reporting that instruments were flashed due to sterile instruments sets unavailable or that the case loads exceeded the number of sets available. Meeting minutes containing infection control for 2009 and 2010 did not demonstrate these issues were identified, analyzed or corrective actions taken.

Based on review of the hospitals's documents, and interviews with staff, the hospital failed to ensure infection control activities and issues were monitored, reviewed and analyzed with corrective actions to prevent, identify and manage infections and communicable diseases with measures that result in improvement on an ongoing basis.

Findings:

1. The hospital did not review the infection control program's sterilization practice with corrective actions to limit the use of unwrapped/"flashed" instruments. The Flash Sterilization Report did not contain areas for reporting that instruments were flashed due to sterile instruments sets unavailable or that the case loads exceeded the number of sets available. Meeting minutes containing infection control for 2009 and 2010 did not demonstrate these issues were identified, analyzed or corrective actions taken.

2. Meeting minutes for the Committee of the Whole (COW) were reviewed for 2010. The only meeting minutes provided for review were 01/13/2010, 02/17/2010, 03/16/2010 and 06/23/2010.

a. COW minutes for 02/17/2010, under Employee Health, documented 11 employees still needed immunizations or signing a waiver. This findings was not followed-up in subsequent meeting minutes. This was the only time for 2010 that Employee Health was addressed.

b. COW minutes for 02/17/2010 and 03/16/2010 documented no infection control reports. There were no COW meeting minutes for April or May.

c. COW minutes for January 13/2010 had as action for hand hygiene surveillance form to recommend approval from the Medical Executive Committee. The next mention of hand hygiene was the attachment on the June COW minutes. The percentage of compliance ranged from 65% (June) to 80% with no data for April or May. Typed at the bottom was an action plan. COW meeting minutes did not address whether the Committee approved this action plan.

d. Staff A showed the surveyors her documentation of surveillance activities she has conducted for June. COW meeting minutes did not contain analysis of this surveillance activities with any corrective actions or suggestions for other surveillance activities. Staff A stated she was using the monitoring tools left by the previous person responsible for infection control and had analyzed their applicability or the need for other types of surveillance.

e. Cow meeting minutes for 03/16/2010 documented Sani-Shield would be the facilities approved disinfectant. The product is safe for home/office use and is not an EPA (Environmental Protection Agency)-registered agent.